What the trial was testing
The ROAR enrolled 206 patients with biliary tract cancer. The study was sponsored by Novartis Pharmaceuticals and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
About 50% tumor response rate in BRAF-mutant biliary tract cancer.
The Lancet Oncology · 2020 · NCT02034110
These findings — that in advanced BRAF-mutant biliary tract cancer on dabrafenib plus trametinib — were published in the The Lancet Oncology and represent the headline result of the study.
Researchers tracked outcomes across 206 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with biliary tract cancer, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Dabrafenib (Tafinlar) plus trametinib (Mekinist) is FDA-approved for any solid tumor with a BRAF V600E mutation, including biliary tract cancer, and available now. Ask an oncologist about BRAF testing on your tumor — most centers test routinely for advanced bile duct cancer.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open biliary tract cancer trials
Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.
A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.